DrugCite

ASPIRIN - aspirin tablet, delayed release 
AAA Pharmaceutical, Inc.

Aspirin Tablets

Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID1)


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains due to:
    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • colds
    • minor pain of arthritis
  • or as recommended by your doctor

Warnings

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs

These could be signs of a serious condition

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 to 2 tablets every 4 hours; do not exceed 12 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

  • store between 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

corn starch, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

RESTORE u

NDC 57344-081-02

COMPARE TO THE ACTIVE
INGREDIENT IN ECOTRIN®
REGULAR STRENGTH

REGULAR
STRENGTH

Enteric Coated Aspirin
Pain Reliever
(NSAID)

Safety
Coated

125 TABLETS - 325 mg each

Principal Display Panel - 125 Tablet Bottle Carton

ASPIRIN 
aspirin  tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 57344-081
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
HYPROMELLOSES  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
CELLULOSE, MICROCRYSTALLINE  
MINERAL OIL  
POLYSORBATE 80  
DIMETHICONE  
SODIUM HYDROXIDE  
SODIUM LAURYL SULFATE  
TALC  
TITANIUM DIOXIDE  
TRIETHYL CITRATE  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code T
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 57344-081-01 1  In 1 CARTON contains a BOTTLE, PLASTIC
1 100  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-081-01)
2 57344-081-02 1  In 1 CARTON contains a BOTTLE, PLASTIC
2 125  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-081-02)
3 57344-081-03 1  In 1 CARTON contains a BOTTLE, PLASTIC
3 250  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-081-03)
4 57344-081-04 1  In 1 CARTON contains a BOTTLE, PLASTIC
4 300  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-081-04)
5 57344-081-05 500  In 1 BOTTLE, PLASTIC None
6 57344-081-06 1000  In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 12/15/2012

Labeler - AAA Pharmaceutical, Inc. (181192162)
Revised: 12/2012AAA Pharmaceutical, Inc.